Cleared Traditional

K905754 - CAPNOMAC ULTIMA ANESTHESIA MONITOR

K905754 is the FDA 510(k) clearance for CAPNOMAC ULTIMA ANESTHESIA MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code CBS) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K905754 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Jun 1991
Decision
175d
Days
Class 2
Risk

K905754 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA ANESTHESIA MONITOR. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on June 17, 1991 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K905754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date June 17, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K905754.
GAS MODULE II, MODEL 0998-00-0143
K974903 · Datascope Corp. · Mar 1998
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
K950101 · Marquette Electronics, Inc. · Mar 1995
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · Hewlett-Packard Co. · Jan 1990
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · Draeger Medical, Inc. · Oct 1987